- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications ... of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure… more
- AbbVie (North Chicago, IL)
- …(https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal ... and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy… more
- Bristol Myers Squibb (Indianapolis, IN)
- …and external stakeholders . Author technical reports and source documents to support regulatory filing. . Author CMC sections for IND/NDA for FDA submissions, ... of your application should be directed to Chat with Ripley. R1596579 : Sr Scientist - Radiopharmaceutical Development & CMC **Company:** Bristol-Myers Squibb… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a ... Senior Manager of Statistics, you will provide statistical leadership in...design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an… more
- BeOne Medicines (Emeryville, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Development, Site Manufacturing Sciences, QA, QC, Engineering, Supply Chain, Validation and Regulatory CMC to ensure aligned, efficient CMC execution ... and technology excellence. + Drive preparation and support of CMC content for regulatory submissions (initial filings,...strengthen supply reliability. + Collaborate closely with an assigned CMC Project Manager (who will provide you… more
- UTMB Health (Huntsville, TX)
- Technical Supervisor, Lab Serv - CMC - Estelle **Huntsville, Texas, United States** Allied Health UTMB Health Requisition # 2505527 The mission of Correctional ... workflow for the division; and communicate with staff, management, and senior leadership. **_ESSENTIAL JOB FUNCTIONS_** **:** . Responsible for recruitment, hiring,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …my knowledge. **Job Description** **Title: Global Manufacturing Sciences BioProcess Lead ( Sr . Manager )** **Location: Zurich, Switzerland / Lexington, MA** ... the biologics portfolio and provide technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products.… more
- Takeda Pharmaceuticals (Boston, MA)
- …reports + investigation reports and technical reports supporting submissions + Provide regulatory CMC support by authoring/reviewing drug substance (and relevant ... development and clinical supply processes. + Demonstrated experience authoring CMC sections for regulatory submissions (eg, IND/IMPD/NDA/MAA). +… more
- Bristol Myers Squibb (San Diego, CA)
- …translating cutting-edge scientific discoveries into robust clinical drug products. The Sr . Scientist will lead CMC radiopharmaceutical process development, ... and mentor junior scientists and associates. + Documentation: Draft and review CMC sections for regulatory submissions, SOPs, and comprehensive development… more
- Takeda Pharmaceuticals (Brooklyn Park, MN)
- …You will also represent the drug product process science perspective in regulatory CMC interactions, translating process understanding into clear and defensible ... unit leaders + Local Technical Services organizations + Global Quality and Regulatory CMC teams + Ensure process knowledge is captured, shared, and reused across… more
- Sanofi Group (Washington, DC)
- …Functional Planner, Project Manager , CROs, etc.) + Under supervision of the senior manager of the TED team or Research lead, participates in project ... **Job Title:** Sr . Non-Clinical Biostatistician **Location:** Swiftwater, PA **About the...bring hope to patients and their families. The Biostatistics Manager of the TED (Translational and Early Development) team… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Supply Chain leads, develops, establishes, and manages the ... working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance,… more
- ThermoFisher Scientific (Greenville, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** ** Senior Director Project Mgmt - Oversight** At Thermo Fisher… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Sr Director, Global Regulatory Strategy, Neuroscience** + Will be a key ... your application should be directed to Chat with Ripley. R1596806 : Senior Director, Global Regulatory Lead Neuroscience **Company:** Bristol-Myers Squibb **Req… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …including but not limited to healthcare antiseptic products. Under the mentorship of the Sr . RA Manager of Regulatory Affairs, they are responsible for ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within...requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **Title: Senior Manager , Commercial Biologics Product Science Lead** **Location: Lexington, MA ... biologics portfolio. In this role, you will be a senior subject matter expert across one or more products...products and provide strong technical expertise and leadership for regulatory interactions, including authoring CMC content for… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Senior Procurement Manager of CMO Category is responsible for establishing, managing and improving all aspects of purchasing ... Supply Chain, CMO Project Managers, Alliance Managers, Quality and CMC Development partners to ensure supply continuity with optimal...supply continuity with optimal cost and quality. Finally, the Senior Procurement Manager will help drive the… more
- Amgen (Thousand Oaks, CA)
- …partners such as Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC , and Supply Chain. The successful candidate will ... lives of patients while transforming your career. **Process Development Senior Scientist** **What you will do** Let's do this....method and validation and transfers + Contribute to global regulatory filings by authoring analytical CMC sections… more
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